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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003542-36 | EudraCT Number | ||
| U1111-1251-5658 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.
Secondary Objectives:
AD participants: A 20-week Observation Period including 16 weeks of treatment for AD participants and a 4-week follow-up period; Healthy participants: 8 days observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants: Control | No Intervention | Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group. | |
| Participants With AD: Dupilumab | Experimental | Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab (SAR231893) | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Baseline, Week 17 |
| Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17 | Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (>60% linear), mainly branched (>60% branched), only branched (100% branched). Percentage of participants with change in nerve fiber branching status from baseline on lesional skin at Week 17 are reported in this outcome measure. | Baseline, Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Weeks 3 and 21 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm^2). |
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Inclusion criteria:
For AD participants
For Healthy participants
Exclusion criteria:
For AD participants
For healthy participants
Regular use (>2 visits per week) of a tanning booth/ parlor within 4 weeks of the Screening Visit.
Treatment with the following concomitant medications and procedures is prohibited within 4 weeks before the Screening Visit or 5 half-lives (whichever is longer) until End of Study Visit:
Any Type 2 immune disorders uncontrolled Type 2 diabetes mellitus, Type 1 diabetes mellitus, neuropathy or any other neurological disease.
Any concomitant illness(es) or conditions that, in the Investigator's judgment, would adversely affect the participant's participation in the study or potentially affect any skin biopsy related read out.
Positive test for immunoglobulin E (IgE) antibodies.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400001 | Miami | Florida | 33136 | United States | ||
| Investigational Site Number 8400002 |
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| Label | URL |
|---|---|
| LPS16763 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Healthy participants were considered as a reference comparator group and received no treatment. Healthy participants underwent only an additional 7-days observational period following collection of the skin biopsy on Day 1 (i.e., up to Day 8). Only safety data was collected for the healthy participants and no other outcome measures were assessed.
The study was conducted at 3 active sites in the United States and Germany. A total of 54 participants were enrolled between 22 April 2021 to 30 March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants: Control | Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected atopic dermatitis (AD) participants, received no treatment, and were considered as a control group. |
| FG001 | Participants With AD: Dupilumab | Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Analysis was performed on enrolled population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants: Control | Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group. |
| BG001 | Participants With AD: Dupilumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Analyzed on modified intent-to-treat (mITT) population which included all AD participants who received at least 1 dose of IMP who had at least 1 skin biopsy performed, irrespective of compliance with study protocol and procedures, and who did not use prohibited therapies for AD from screening to end of study. 'Overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | F/mm^2 | Baseline, Week 17 |
For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants: Control | Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymptomatic Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2021 | Jun 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2022 | Jun 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Healthy participants served as control group providing normal skin reference for baseline skin biopsy derived outcome measure and were matched for gender, age, race and anatomical site of skin biopsy.
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| Baseline, Weeks 3 and 21 |
| Change From Baseline in Nerve Fiber Branching on Lesional Skin at Weeks 3 and 21 | Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (>60% linear), mainly branched (>60% branched), only branched (100% branched). | Baseline, Weeks 3 and 21 |
| Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21 | Peak Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21 | EASI was a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, and edema], scratching [excoriation], and lichenification) were each assessed for severity by the Investigator on a scale of "0" (absent) through "3" (severe). EASI area score was based upon percent (%) body surface area (BSA) with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score was derived as the sum of the 4 region scores and ranged from 0 (minimum) to 72 (maximum). Higher scores indicated greater severity of AD. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21 | SCORAD was used to standardize the extent and severity of AD. It consisted of 3 components i.e., A =extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0"=no itch (or no sleeplessness) and "10"=worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7*B/2+ C. SCORAD total score ranged from 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21 | PROMIS-itch represents a novel suite of participant-reported outcome (PRO) measures for the itch. The PROMIS-Itch severity score consists of 7 questions: 4 questions scored on a scale of 1 to 5: 1) How intense was your itch at its worst; 2) How intense was your itch in general; 3) What is your level of itch right now; 4) How often did you feel the itch; and rest 3 questions (same questions as 1 to 3 mentioned before but scaled on a scale of 0 to 10) were scored on a scale of 0 to 10. Higher scores for each question indicated worse outcome. The total PROMIS-itch score was calculated as the sum of the 7 questions and ranged from 4 (better outcome) to 50 (worse outcome), where a higher score indicated worse condition. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21 | The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21 | DLQI was a 10-item PRO questionnaire that measured the impact of AD disease symptoms and treatment on quality of life. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score that ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21 | ADCT was a PRO questionnaire designed to assess participant-self-perceived control of their eczema. ADCT contained 6 items allowing a comprehensive coverage of the dimensions defining AD control, i.e., overall severity of AD symptoms, frequency of intense episodes of itching, extent of AD related bother, impact on sleep, impact on daily activities, impact on mood or emotions. Each item of the ADCT is rated from 0 (no problem) to 4 (worst) Likert scale and is equally weighted. The sum of the 6 items gives the total score that ranged from 0 (best disease control) to 24 (worst disease control). Higher scores indicate lower AD control. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21 | Sleep quality NRS was used to assess the quality of the participant's previous night's sleep using a 0 ("Worst possible sleep") to 10 ("Best possible sleep") NRS. Participants were asked to complete the following question upon awakening: "Select the number (0 to 10) that best describes the quality of your sleep last night". Higher score indicated better outcome. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21 | Skin pain NRS was used to assess participant's skin pain at its worst in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21 | Skin sensitivity NRS was a 1 item PRO measure asking the participants to rate their skin sensitivity to touch using a 0 ("Normal") to 10 ("Extremely sensitive") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How sensitive was your skin at its worst in the past 24 hours?" Lower score indicated better outcome. | Baseline, Weeks 17 and 21 |
| Change From Baseline in Skin Burning Numerical Rating Scale Score at Weeks 17 and 21 | Skin burning NRS was a 1-item PRO measure asking participants to rate the burning sensation of their skin in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome. | Baseline, Weeks 17 and 21 |
| Percentage of Participants With Change of Greater Than or Equal to (>=4) Point in Pruritus Numerical Rating Scale From Baseline at Weeks 17 and 21 | Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity. Percentage of participants with change of >=4 point in pruritus NRS scale from baseline at Weeks 17 and 21 are reported in this outcome measure. | Baseline, Weeks 17 and 21 |
| East Windsor |
| New Jersey |
| 08520 |
| United States |
| Investigational Site Number 2760001 | Münster | 48149 | Germany |
| Other-unspecified |
|
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Participants With AD: Dupilumab | Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15. |
|
|
| Primary | Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17 | Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (>60% linear), mainly branched (>60% branched), only branched (100% branched). Percentage of participants with change in nerve fiber branching status from baseline on lesional skin at Week 17 are reported in this outcome measure. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Number | percentage of participants | Baseline, Week 17 |
|
|
|
| Secondary | Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Weeks 3 and 21 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm^2). | Data was not collected and analyzed for this outcome measure as no optional skin biopsies were done at Weeks 3 and 21. | Posted | Baseline, Weeks 3 and 21 |
|
|
| Secondary | Change From Baseline in Nerve Fiber Branching on Lesional Skin at Weeks 3 and 21 | Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (>60% linear), mainly branched (>60% branched), only branched (100% branched). | Data was not collected and analyzed for this outcome measure as no optional skin biopsies were done at Weeks 3 and 21. | Posted | Baseline, Weeks 3 and 21 |
|
|
| Secondary | Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21 | Peak Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
|
| Secondary | Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21 | EASI was a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, and edema], scratching [excoriation], and lichenification) were each assessed for severity by the Investigator on a scale of "0" (absent) through "3" (severe). EASI area score was based upon percent (%) body surface area (BSA) with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score was derived as the sum of the 4 region scores and ranged from 0 (minimum) to 72 (maximum). Higher scores indicated greater severity of AD. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
|
| Secondary | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21 | SCORAD was used to standardize the extent and severity of AD. It consisted of 3 components i.e., A =extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0"=no itch (or no sleeplessness) and "10"=worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7*B/2+ C. SCORAD total score ranged from 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
|
| Secondary | Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21 | PROMIS-itch represents a novel suite of participant-reported outcome (PRO) measures for the itch. The PROMIS-Itch severity score consists of 7 questions: 4 questions scored on a scale of 1 to 5: 1) How intense was your itch at its worst; 2) How intense was your itch in general; 3) What is your level of itch right now; 4) How often did you feel the itch; and rest 3 questions (same questions as 1 to 3 mentioned before but scaled on a scale of 0 to 10) were scored on a scale of 0 to 10. Higher scores for each question indicated worse outcome. The total PROMIS-itch score was calculated as the sum of the 7 questions and ranged from 4 (better outcome) to 50 (worse outcome), where a higher score indicated worse condition. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
|
| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21 | The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21 | DLQI was a 10-item PRO questionnaire that measured the impact of AD disease symptoms and treatment on quality of life. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score that ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
|
|
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| Secondary | Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21 | ADCT was a PRO questionnaire designed to assess participant-self-perceived control of their eczema. ADCT contained 6 items allowing a comprehensive coverage of the dimensions defining AD control, i.e., overall severity of AD symptoms, frequency of intense episodes of itching, extent of AD related bother, impact on sleep, impact on daily activities, impact on mood or emotions. Each item of the ADCT is rated from 0 (no problem) to 4 (worst) Likert scale and is equally weighted. The sum of the 6 items gives the total score that ranged from 0 (best disease control) to 24 (worst disease control). Higher scores indicate lower AD control. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
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|
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| Secondary | Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21 | Sleep quality NRS was used to assess the quality of the participant's previous night's sleep using a 0 ("Worst possible sleep") to 10 ("Best possible sleep") NRS. Participants were asked to complete the following question upon awakening: "Select the number (0 to 10) that best describes the quality of your sleep last night". Higher score indicated better outcome. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
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| Secondary | Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21 | Skin pain NRS was used to assess participant's skin pain at its worst in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
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| Secondary | Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21 | Skin sensitivity NRS was a 1 item PRO measure asking the participants to rate their skin sensitivity to touch using a 0 ("Normal") to 10 ("Extremely sensitive") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How sensitive was your skin at its worst in the past 24 hours?" Lower score indicated better outcome. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
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| Secondary | Change From Baseline in Skin Burning Numerical Rating Scale Score at Weeks 17 and 21 | Skin burning NRS was a 1-item PRO measure asking participants to rate the burning sensation of their skin in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 17 and 21 |
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| Secondary | Percentage of Participants With Change of Greater Than or Equal to (>=4) Point in Pruritus Numerical Rating Scale From Baseline at Weeks 17 and 21 | Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity. Percentage of participants with change of >=4 point in pruritus NRS scale from baseline at Weeks 17 and 21 are reported in this outcome measure. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol. | Posted | Number | percentage of participants | Baseline, Weeks 17 and 21 |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Participants With AD: Dupilumab | Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15. | 0 | 31 | 1 | 31 | 24 | 31 |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Suspected Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Tinea Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Food Poisoning | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Pain Of Skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection Site Mass | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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